Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017549
Company: MERIDIAN MEDCL TECHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIDOPEN LIDOCAINE HYDROCHLORIDE 10% INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/28/1975 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/2000 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/08/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/21/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/18/1997 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/10/1993 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1988 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/10/1986 SUPPL-11 Labeling

Label is not available on this site.

04/16/1984 SUPPL-8 Labeling

Label is not available on this site.

01/11/1978 SUPPL-7 Labeling

Label is not available on this site.

03/17/1977 SUPPL-4 Labeling

Label is not available on this site.

10/18/1976 SUPPL-3 Efficacy

Label is not available on this site.

12/04/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1975 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English